Pure and Simple Kids 50

Manufacturer
Bayer HealthCare LLC.
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:09:11

Label at a glance#

ProductPure and Simple Kids 50
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Uses ■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Zinc Oxide 20%

OTC - PURPOSE SECTION

Purpose

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Uses

■ helps prevent sunburn

■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

■ apply liberally 15 minutes before sun exposure

■ reapply:

■ after 80 minutes of swimming or sweating

■ immediately after towel drying

■ at least every 2 hours

■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

■ limit time in the sun, especially from 10 a.m. – 2 p.m.

■ wear long-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months: Ask a doctor

Other information

OTHER SAFETY INFORMATION

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT SECTION

Inactive ingredients cocos nucifera (coconut) oil, behenyl behenate, helianthus annuus (sunflower) seed oil, theobroma cacao (cocoa) seed butter, polyhydroxystearic acid, ricinus communis (castor) seed oil, squalane, helianthus annuus (sunflower) seed wax, butyrospermum parkii (shea butter), euphorbia cerifera (candelilla) wax, tocopherol, caprylic/capric triglyceride, simmondsia chinensis (jojoba) seed oil, aloe barbadensis leaf extract

OTC - QUESTIONS SECTION

Questions? 1-866-288-3330

Package label display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 Pediatrician

Recommended Brand

Coppertone®

SUNSCREEN STICK

Pure &

Simple

kids® + cocoa butter

50

Hypoallergenic

& Gentle

No PABA, Parabens,

Phthlates, Fragrances,

Dyes, Oxybenzone

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

NET WT .49 OZ (13.9g)

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-747611523-7476-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
994b6565-24c3-6b4a-e053-2a95a90aa80b91c08b6f-0b84-cd02-e053-2a95a90adf692019-12-09WarningsExact identifier
spl id: 994b6565-24c3-6b4a-e053-2a95a90aa80b
spl set id: 91c08b6f-0b84-cd02-e053-2a95a90adf69

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.